Thursday, 20 September, 2018

FDA approves its first marijuana-derived drug

FDA approves first cannabis-based drug	 	 	 			Courtesy CNN FDA approves first cannabis-based drug Courtesy CNN
Anna Jefferson | 26 June, 2018, 22:15

The drug, GW Pharmaceuticals' Epidiolex, is made of cannabidiol, or CBD, a component of marijuana that does not give users a high.

The U.S. health regulator approved GW Pharmaceuticals Plc's epilepsy treatment on Monday, making it the first cannabis-based drug to win approval in the country and opening floodgates for more research into the medicinal properties of cannabis. United Kingdom -based GW Pharmaceuticals says the solution, taken by mouth, is made from a proprietary strain of cannabis created to maximize a therapeutic component while minimizing components that produce euphoria.

The oral solution contains cannabidiol, or CBD, a nonpsychoactive compound that has proved beneficial in reducing the catastrophic, potentially life-threatening seizures that accompany both conditions. Where is weed legal?

"The FDA prepares and transmits... a medical and scientific analysis of substances subject to scheduling, like CBD, and provides recommendations to the Drug Enforcement Administration (DEA) regarding controls under the [Controlled Substances Act]", the FDA stated, indicating that it will recommend that CBD be rescheduled but the act of shifting the substance's legality is ultimately in the DEA's hands.

Shlomo Shinnar, president of the American Epilepsy Society and a neurologist at Montefiore Medical Center in NY, has said the drug will be "a very valuable addition" to the limited options for treating severe childhood-onset epilepsy.

There are likely to be drug interactions, she said, but "that's not uncommon for antiepileptic medications", and she noted that this could affect the effectiveness of the medication.

This drug is a treatment option of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. According to the New York Times, analysts expect Epidiolex to cost $2,500 to $5,000 a month. Carreno says that a leader drug like Epidiolex often paves the way for other less expensive-and untested-CBD products.

The approval of Epidiolex may help open the door to more CBD research, as it helps to lift one regulatory hurdle.

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A government-regulated version of the oil will ease some doubts about the amount of CBD in the product, which can vary based on its origin, said Dr. Elaine Wirrell, director of the Mayo Clinic's child epilepsy program. The FDA has previously sent warning letters to companies that hyped their products as cancer or Alzheimer's fighters.

It's not clear how quickly the drug will be available for prescription.

Nine states plus Washington, D.C., have legalized medical marijuana, and the FDA said even more are considering it, particularly after it approved Epidolex.

Despite increasing acceptance, there is little rigorous research on the benefits and harms of marijuana. This treatment we have studied for the last five years.

Epidiolex was recommended for approval by an advisory committee in April, and the agency had until this week to make a decision.

As a result, Epidiolex's launch remains at the discretion of the DEA which must now evaluate the drug and consider reclassifying it as a substance that has medical properties, which would allow GW to begin selling it.

Gottlieb emphasized that the approval of Epidiolex does not have any implications for the approval of marijuana as a medicine more broadly, but the move is still widely seen by the industry as a significant step towards acceptance of the cannabis plant.

The European Medicines Agency is expected to rule on the therapy in early 2019.

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